U.S. patent number 8,498,693 [Application Number 13/082,463] was granted by the patent office on 2013-07-30 for intracorporeal marker and marker delivery device.
This patent grant is currently assigned to Senorx, Inc.. The grantee listed for this patent is Michael L. Jones, Paul Lubock, John Merritt. Invention is credited to Michael L. Jones, Paul Lubock, John Merritt.
United States Patent |
8,498,693 |
Jones , et al. |
July 30, 2013 |
Intracorporeal marker and marker delivery device
Abstract
An elongated intracorporeal remotely detectable marker includes
a core of bioabsorbable fibers. An outer jacket of bioabsorbable
fibers is disposed around at least part of the core. In one
embodiment, for example, the core has a longitudinal extent and a
pair of opposed ends, and the outer jacket is disposed around the
longitudinal extent of the core, with the pair of opposed ends
being exposed.
Inventors: |
Jones; Michael L. (San
Clemente, CA), Lubock; Paul (Monarch Beach, CA), Merritt;
John (San Clemente, CA) |
Applicant: |
Name |
City |
State |
Country |
Type |
Jones; Michael L.
Lubock; Paul
Merritt; John |
San Clemente
Monarch Beach
San Clemente |
CA
CA
CA |
US
US
US |
|
|
Assignee: |
Senorx, Inc. (Tempe,
AZ)
|
Family
ID: |
44309478 |
Appl.
No.: |
13/082,463 |
Filed: |
April 8, 2011 |
Prior Publication Data
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|
|
Document
Identifier |
Publication Date |
|
US 20110184280 A1 |
Jul 28, 2011 |
|
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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12214398 |
Jun 18, 2008 |
7970454 |
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10753694 |
Jan 7, 2004 |
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10444770 |
May 23, 2003 |
7983734 |
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13082463 |
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12852286 |
Aug 6, 2010 |
8219182 |
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10990327 |
Nov 16, 2004 |
7792569 |
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10124757 |
Apr 16, 2002 |
6862470 |
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09717909 |
Nov 20, 2000 |
6725083 |
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09343975 |
Jun 30, 1999 |
6347241 |
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09241936 |
Feb 2, 1999 |
6161034 |
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13082463 |
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12592020 |
Nov 18, 2009 |
8177792 |
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10174401 |
Jun 17, 2002 |
7651505 |
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Current U.S.
Class: |
600/431; 600/414;
600/424; 600/407; 600/426; 600/420; 600/437 |
Current CPC
Class: |
A61B
90/39 (20160201); A61B 17/0057 (20130101); A61B
2090/3987 (20160201); A61B 2090/3908 (20160201); A61B
2017/00637 (20130101); A61B 2090/3925 (20160201); A61B
2017/00898 (20130101) |
Current International
Class: |
A61B
5/00 (20060101) |
Field of
Search: |
;60/407,414,420,424,426,431,437
;600/407,414,420,424,426,431,437 |
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Primary Examiner: Luong; Peter
Parent Case Text
RELATED APPLICATIONS
This application is a continuation-in-part of application Ser. No.
12/214,398 entitled MARKER DELIVERY DEVICE WITH RELEASABLE PLUG,
filed Jun. 18, 2008, now U.S. Pat. No. 7,970,454, which is a
divisional of application Ser. No. 10/753,694, filed Jan. 7, 2004
now abandoned, which is a continuation-in-part of application Ser.
No. 10/444,770, filed May 23, 2003, now U.S. Pat. No.
7,983,734.
Also, this application is a continuation-in-part of U.S. patent
application Ser. No. 12/852,286 entitled CAVITY-FILLING BIOPSY SITE
MARKERS, filed Aug. 6, 2010, now U.S. Pat. No. 8,219,182, which is
a continuation of U.S. patent application Ser. No. 10/990,327,
filed Nov. 16, 2004, now U.S. Pat. No. 7,792,569, which is a
continuation of U.S. patent application Ser. No. 10/124,757, filed
Apr. 16, 2002, now U.S. Pat. No. 6,862,470, which is a
continuation-in-part of U.S. patent application Ser. No.
09/717,909, filed Nov. 20, 2000, now U.S. Pat. No. 6,725,083, which
is a continuation-in-part of U.S. patent application Ser. No.
09/343,975, filed Jun. 30, 1999, now U.S. Pat. No. 6,347,241, which
is a continuation-in-part of U.S. patent application Ser. No.
09/241,936, filed Feb. 2, 1999, now U.S. Pat. No. 6,161,034.
Also, this application is a continuation-in-part of U.S. patent
application Ser. No. 12/592,020 entitled PLUGGED TIP DELIVERY TUBE
FOR MARKER PLACEMENT, filed Nov. 18, 2009, now U.S. Pat. No.
8,177,792, which is a continuation of U.S. patent application Ser.
No. 10/174,401, filed Jun. 17, 2002, now U.S. Pat. No.
7,651,505.
All the above from which priority is claimed are incorporated
herein by reference in their entireties.
Claims
What is claimed is:
1. A remotely detectable elongated intracorporeal marker,
comprising: a core of bioabsorbable fibers; and an outer jacket of
bioabsorbable fibers disposed around at least part of the core.
2. The intracorporeal marker of claim 1, wherein the core has a
longitudinal extent and a pair of opposed ends, and the outer
jacket is disposed around the longitudinal extent of the core and
with the pair of opposed ends being exposed.
3. The intracorporeal marker of claim 1, further comprising a
radiopaque marker element disposed around the outer jacket.
4. The intracorporeal marker of claim 1, wherein the bioabsorbable
fibers of the core comprise at least one material selected from the
group consisting of cellulose, polylactic acid, a copolymer of
polylactic acid and glycolic acid, and polycaprolactone.
5. The intracorporeal marker of claim 4, wherein the cellulose is
oxidized, regenerated cellulose.
6. The intracorporeal marker of claim 1, wherein the outer jacket
is at least in part woven fabric.
7. The intracorporeal marker of claim 1, wherein the marker is in a
compressed condition, and maintained in the compressed condition by
having incorporated therein a binding agent.
8. The intracorporeal marker of claim 7, wherein the binding agent
is at least one water soluble polymer selected from the group
consisting of polyvinyl alcohol, polyethylene glycol and polyvinyl
pyrollidone.
9. The intracorporeal marker of claim 1, comprising at least one
bioactive component selected from the group consisting of
therapeutic and diagnostic agents incorporated therein.
10. The intracorporeal marker of claim 1, wherein the core includes
a material selected from the group consisting of polylactic acid, a
co-polymer of polylactic acid and glycolic acid, polycaprolactone,
collagen and mixtures thereof, including mixtures with an oxidized
cellulose.
11. The intracorporeal marker of claim 1, comprising a radiopaque
marker element disposed around a central portion of the outer
jacket.
12. The intracorporeal marker of claim 11, wherein the radiopaque
marker element holds the central portion to restrict expansion
thereof.
13. The intracorporeal marker of claim 12, wherein the outer jacket
is configured to expand into a bow-tie shape when exposed to body
fluid or other water based fluid.
14. The intracorporeal marker of claim 1 which has been compressed
at least 25%, and is bound in a compressed bound condition by a
polymer binding agent selected from the group of water soluble
polymers consisting of polyvinyl alcohol, polyethylene glycol and
polyvinyl pyrollidone.
15. The intracorporeal marker of claim 1, which is about 0.5 mm to
about 12 mm in diameter and about 5 to about 30 mm in length.
16. The intracorporeal marker of claim 1, wherein the bioabsorbable
fibers of the outer jacket comprise at least one material selected
from the group consisting of oxidized cellulose, oxidized
regenerated cellulose, polylactic acid, a copolymer of polylactic
acid and glycolic acid, and polycaprolactone.
17. A remotely imageable marker system for an intracorporeal site,
comprising: a first tissue marker pellet comprised of a
polysaccharide, the polysaccharide exhibiting hemostatic
properties; and a second tissue marker for delivery to a patient
site with the first tissue marker pellet, the second tissue marker
configured as a fibrous marker comprising: a core of bioabsorbable
fibers; and an outer jacket of bioabsorbable fibers disposed around
at least part of the core.
Description
FIELD OF THE INVENTION
The invention is generally directed to devices and methods for the
delivery of remotely detectable markers to a desired location
within a patient's body. In particular, the invention is directed
to devices and methods configured to retain a remotely detectable
marker within a delivery device before delivery to a desired
intracorporeal location.
BACKGROUND OF THE INVENTION
In diagnosing and treating certain medical conditions, it is often
desirable to mark a suspicious body site for the subsequent taking
of a biopsy specimen, for delivery of medicine, radiation, or other
treatment, for the relocation of a site from which a biopsy
specimen was taken, or at which some other procedure was performed.
As is known, obtaining a tissue sample by biopsy and the subsequent
examination are typically employed in the diagnosis of cancers and
other malignant tumors, or to confirm that a suspected lesion or
tumor is not malignant. The information obtained from these
diagnostic tests and/or examinations is frequently used to devise a
therapeutic plan for the appropriate surgical procedure or other
course of treatment.
In many instances, the suspicious tissue to be sampled is located
in a subcutaneous site, such as inside a human breast. To minimize
surgical intrusion into a patient's body, it is often desirable to
insert a small instrument, such as a biopsy needle, into the body
for extracting the biopsy specimen while imaging the procedure
using fluoroscopy, ultrasonic imaging, x-rays, magnetic resonance
imaging (MRI) or any other suitable form of imaging technique.
Examination of tissue samples taken by biopsy is of particular
significance in the diagnosis and treatment of breast cancer. In
the ensuing discussion, the biopsy and treatment site described
will generally be the human breast, although the invention is
suitable for marking biopsy sites in other parts of the human and
other mammalian body as well.
Periodic physical examination of the breasts and mammography are
important for early detection of potentially cancerous lesions. In
mammography, the breast is compressed between two plates while
specialized x-ray images are taken. If an abnormal mass in the
breast is found by physical examination or mammography, ultrasound
may be used to determine whether the mass is a solid tumor or a
fluid-filled cyst. Solid masses are usually subjected to some type
of tissue biopsy to determine if the mass is cancerous.
If a solid mass or lesion is large enough to be palpable, a tissue
specimen can be removed from the mass by a variety of techniques,
including but not limited to open surgical biopsy, a technique
known as Fine Needle Aspiration Biopsy (FNAB) and instruments
characterized as "vacuum assisted large core biopsy devices".
If a solid mass of the breast is small and non-palpable (e.g., the
type typically discovered through mammography), a vacuum assisted
large core biopsy procedure is usually used. In performing a
stereotactic biopsy of a breast, the patient lies on a special
biopsy table with her breast compressed between the plates of a
mammography apparatus and two separate x-rays or digital video
views are taken from two different points of view. A computer
calculates the exact position of the lesion as well as depth of the
lesion within the breast. Thereafter, a mechanical stereotactic
apparatus is programmed with the coordinates and depth information
calculated by the computer, and such apparatus is used to precisely
advance the biopsy needle into the small lesion. The stereotactic
technique may be used to obtain histologic specimens. Usually at
least five separate biopsy specimens are obtained from locations
around the small lesion as well as one from the center of the
lesion.
The available treatment options for cancerous lesions of the breast
include various degrees of mastectomy or lumpectomy, radiation
therapy, chemotherapy and combinations of these treatments.
However, radiographically visible tissue features, originally
observed in a mammogram, may be removed, altered or obscured by the
biopsy procedure, and may heal or otherwise become altered
following the biopsy. In order for the surgeon or radiation
oncologist to direct surgical or radiation treatment to the precise
location of the breast lesion several days or weeks after the
biopsy procedure was performed, it is desirable that a biopsy site
marker be placed in the patient's body to serve as a landmark for
subsequent location of the lesion site. A biopsy site marker may be
a permanent marker (e.g., a metal marker visible under x-ray
examination), or a temporary marker (e.g., a bioresorbable marker
detectable with ultrasound). While current radiographic type
markers may persist at the biopsy site, an additional mammography
generally must be performed at the time of follow up treatment or
surgery in order to locate the site of the previous surgery or
biopsy. In addition, once the site of the previous procedure is
located using mammography, the site must usually be marked with a
location wire which has a hook on the end which is advanced into
site of the previous procedure. The hook is meant to fix the tip of
the location wire with respect to the site of the previous
procedure so that the patient can then be removed from the
confinement of the mammography apparatus and the follow-up
procedure performed. However, as the patient is removed from the
mammography apparatus, or otherwise transported the position of the
location wire can change or shift in relation to the site of the
previous procedure. This, in turn, can result in follow-up
treatments being misdirected to an undesired portion of the
patient's tissue.
As an alternative or adjunct to radiographic imaging, ultrasonic
imaging (herein abbreviated as "USI") or visualization techniques
can be used to image the tissue of interest at the site of interest
during a surgical or biopsy procedure or follow-up procedure. USI
is capable of providing precise location and imaging of suspicious
tissue, surrounding tissue and biopsy instruments within the
patient's body during a procedure. Such imaging facilitates
accurate and controllable removal or sampling of the suspicious
tissue so as to minimize trauma to surrounding healthy tissue.
For example, during a breast biopsy procedure, the biopsy device is
often imaged with USI while the device is being inserted into the
patient's breast and activated to remove a sample of suspicious
breast tissue. As USI is often used to image tissue during
follow-up treatment, it may be desirable to have a marker, similar
to the radiographic markers discussed above, which can be placed in
a patient's body at the site of a surgical procedure and which are
visible using USI. Such a marker enables a follow-up procedure to
be performed without the need for traditional radiographic
mammography imaging which, as discussed above, can be subject to
inaccuracies as a result of shifting of the location wire as well
as being tedious and uncomfortable for the patient.
Placement of a marker or multiple markers at a location within a
patient's body requires delivery devices capable of holding markers
within the device until the device is properly situated within a
breast or other body location. Accordingly, devices and methods for
retaining markers within a marker delivery device while allowing
their expulsion from the devices at desired intracorporeal
locations are desired.
SUMMARY OF THE INVENTION
The invention is generally directed to the delivery of one or more
markers to an intracorporeal site within a patient's body. A marker
delivery device embodying features of the invention include a
delivery tube or cannula having an inner lumen leading to a
discharge opening and having a releasable plug which is disposed at
least in part within the inner lumen and which at least partially
occludes the discharge opening in the distal end of the delivery
tube.
The invention, in one form thereof, is directed to a remotely
detectable elongated intracorporeal marker. The marker includes a
core of bioabsorbable fibers. An outer jacket of bioabsorbable
fibers is disposed around at least part of the core. In one
embodiment, for example, the core has a longitudinal extent and a
pair of opposed ends, and the outer jacket is disposed around the
longitudinal extent of the core, with the pair of opposed ends
being exposed.
According to another embodiment of the invention, a releasable plug
may be configured to occlude or block off the discharge opening of
the delivery cannula or the inner lumen leading thereto to prevent
tissue and fluid from entering the inner lumen through the
discharge opening during delivery and to hold in any other markers
within the inner lumen proximal to the releasable plug during
handling and delivery. In one embodiment having features of the
invention, the delivery device has a releasable plug with a
remotely detectable marker element incorporated therein.
Preferably, the marker element incorporated into the releasable
plug is non-magnetic and remotely detectable by magnetic resonance
imaging.
In yet another embodiment having features of the invention, the
delivery device has a releasable plug and has at least one short
term, remotely detectable marker mass in the inner lumen or at
least one fibrous marker in the inner lumen proximal to the
releasable plug. Preferably, at least one short term marker and at
least one fibrous marker are disposed within the inner lumen of the
delivery cannula.
The releasable plug may be secured within the inner lumen by a
variety of means, but It is preferred to press fit the plug into
the distal portion of the inner lumen so as to occlude the
discharge opening. However, the plug may alternatively be
mechanically or adhesively secured within the distal portion of the
inner lumen. For further plug details see application Ser. No.
10/174,401, now U.S. Pat. No. 7,651,505, entitled Plugged Tip
Delivery Tube For Marker Placement which is incorporated herein in
its entirety by reference. However, the releasable plug should be
configured to be easily pushed out of the discharge opening of the
delivery cannula, even if the releasable plug has swollen due to
contact with a water based fluid. As described above, the
releasable plug preferably has a non-magnetic, MRI detectable
element which does not interfere with the subsequent imaging of
adjacent tissue. The MRI detectable element is about 0.5 to about 5
mm in maximum dimension, preferably about 1 to about 3 mm. Suitable
non-magnetic, MRI detectable materials include titanium, platinum,
gold, iridium, tantalum, tungsten, silver, rhodium and the
like.
The releasable plug is formed of a biocompatible, preferably
bioabsorbable material such as oxidized regenerated cellulose,
polyethylene glycol, polylactic acid, polyglycolic acid,
polycaproic acid, and copolymers, polymer alloys, polymer blends,
and combinations thereof. Preferable materials are oxidized
regenerated cellulose and polymers of polyethylene glycol with
molecular weights of about 5000 to about 120,000 Daltons. The
releasable plug should be formed of a water swellable material, so
that it swells upon contact with water based fluids (e.g. body
fluids) to further occlude or otherwise seal the discharge opening
of the delivery cannula and thereby prevent premature contact of
body fluids with any markers within the inner lumen proximal to the
releasable plug. The plug may also be formed of fibrous materials
and be in the form of a fibrous marker described below.
The short term markers disposed within the inner lumen of the
delivery cannula proximal to the releasable plug should be remotely
detectable for at least two weeks, preferably at least up to six
weeks, but not longer than about one year, preferably not more than
about six months, so as to not interfere with subsequent imaging of
the target site. The short term markers are preferably formed of
bioabsorbable polymeric materials such as polymers of lactic acid,
glycolic acid and caprolactones and copolymers and blends thereof.
Other suitable materials include those described in application
Ser. No. 09/717,909, now U.S. Pat. No. 6,752,083, and application
Ser. No. 10/124,757, now U.S. Pat. No. 6,862,470, both of which are
incorporated by reference in their entireties. The plug and the
short term markers may be formed of the same or similar material.
The releasable plug may also be formed of fibrous material and be
in the form of the fibrous markers described below.
The fibrous marker should be slidably disposed within the inner
lumen of the delivery cannula, preferably proximal to at least one
short term marker so that upon discharge from the cannula into a
target site, the fibrous marker will block the accessing passageway
and prevent loss of marker material therethrough. A suitable
material for forming the fibrous marker is a felt and/or fiber
material formed of oxidized regenerated cellulose which has an in
vivo lifetime of a few hours up to about 6 weeks, typically about 3
days to about 4 weeks. However, the fibrous marker may be formed of
a bioabsorbable polymer such as polylactic acid or polyglycolic
acid, a co-polymer of polylactic acid and polyglycolic acid,
polycaprolactone, collagen and mixtures thereof, including mixtures
with oxidized regenerated cellulose. Suitable oxidized, regenerated
cellulose includes SURGICEL.TM. from the Ethicon Division of
Johnson & Johnson or other suitable oxidized regenerated
cellulose which are naturally hemostatic. Alternatively, a
hemostatic agent such as collagen, gelatin or polysaccharides may
be incorporated into the fibrous material to provide the hemostasis
upon contact with blood. A wide variety of other hemostatic agents
may be incorporated into the marker. The thrombus formed by the
hemostasis is formed very quickly to fill the cavity at the biopsy
site and at least temporarily hold the plug and any other markers
in position within the cavity. Anesthetic agents to control post
procedure pain, chemotherapeutic agents to kill any residual
neoplastic tissue and coloring agents (e.g. carbon black and
methylene blue) for visual location of the biopsy site, may also be
incorporated into the fibrous marker.
The fibrous material is formed into an elongated member, e.g. by
rolling or folding, and bound in a compressed condition to provide
sufficient column strength to facilitate introduction into and
discharge from a tubular delivery device. Suitable binding agents
for holding the fibrous marker in a compressed condition are water
soluble polymers such as polyvinyl alcohol, polyethylene glycol,
polyvinyl pyrollidone. One or more radiographically detectable
marker elements are provided with at least one of the fibrous
markers, preferably centrally located on the elongated marker to
ensure that the radiographically detectable element is disposed at
a more or less central location within the target site rather than
at a site margin.
The releasable plug, the short term markers and the fibrous markers
may include a variety of therapeutic or diagnostic materials such
as hemostatic agents, anesthetic agents, coloring agents,
antibiotics, antifungal agents, antiviral agents, chemotherapeutic
agents, radioactive agents and the like.
The delivery device preferably has a plunger slidably disposed
within the inner lumen of the delivery cannula which is movable
from an initial position accommodating the releasable plug and any
markers proximal to the plug within the tube, to a delivery
position to push the plug and any desired number of markers out of
the discharge opening in the distal end of the cannula into the
target tissue site.
Upon being discharged into the intracorporeal target site, the
markers at least partially fill the site to enable short term
detection by remote imaging and preferably long term detection by
remote imaging without interfering with imaging of tissue adjacent
to the site. The markers may swell on contact with body fluid, e.g.
blood so as to further fill the biopsy cavity. The fibrous marker
partially fills the cavity at the target site, positioning the
radiopaque marker element within the interior of the target
cavity.
The marker mass proximal to the releasable plug may be in the form
of ultrasound-detectable, bio-resorbable finely-divided particulate
material (such as a powder or granulated material), in which many
of the particles have internal cavities. Such particulate materials
preferably have particle sizes less than about 2000 microns, and
typically between about 20 microns and about 2000 microns. For
optimum delivery and marker resolution, the particulate should have
a particulate size of about 20 microns to about 1500 microns,
preferably about 500 microns to about 800 microns. The
ultrasound-detectable, bio-resorbable particulate materials may be
formed of polymeric materials such as polylactic acid, polyglycolic
acid, polycaprolactone, and combinations of these polymers and the
particulate may be bound by suitable binding agents such as
gelatin, polyethylene glycol, polyvinyl alcohol, glycerin,
polysaccharides, other hydrophilic materials, and combinations of
these. Suitable gelatins include bovine collagen, porcine collagen,
ovine collagen, equine collagen, synthetic collagen, agar,
synthetic gelatin, and combinations of these. Further details of
the particulate marker material and the delivery thereof can be
found in application Ser. No. 10/124,757, now U.S. Pat. No.
6,862,470, which has been incorporated herein. Polysaccharide
particulate or powder may be included with the other particulate
materials as a hemostatic agent.
The delivery tube of the device may be configured to fit within a
guide cannula, such as a Mammotome.RTM. or SenoCor360.TM. biopsy
cannula or a coaxial needle guide.
The ultrasound-detectable biopsy site markers of the present
invention provide several advantages. A biopsy cavity with marker
material having features of the present invention provides a large
USI-bright mass, making it much easier, for example, to distinguish
the ultrasound signal of the marker from signals arising naturally
from within a breast. The marker materials produce bright
ultrasound echo signals from one portion of the filled region,
which contrasts with the dark ultrasound shadow region immediately
behind the bright ultrasound echo region. The strength of the
reflected signal, and the contrast with the shadow region, make the
marked site readily detectable. Such ready detectability allows,
for example, less-experienced physicians to perform the
identification by USI and the subsequent surgical resection without
the need for an interventional radiologist to identify and mark the
biopsy cavity. When a MRI marker element is incorporated into the
releasable plug or the short term markers, the target site in which
the markers are deployed may be subsequently detected by
ultrasound, magnetic resonance and X-ray without interfering with
imaging adjacent tissue at a later date.
One advantage of the embodiment of the invention directed to the
elongated intracorporeal remotely detectable marker having a core
and outer jacket is that by having a two layer core/jacket marker
body, upon contact with a body fluid or other water based fluid,
the length of the fibrous marker remains about the same but the
wrapped structure unfolds upon swelling. This "unfolding" creates
more surface area subject to exposure to the fluid to enhance
expansion, and potentially provides a larger imaging characteristic
than would be possible with an unwrapped single layer marker of
similar initial shape, i.e., a core alone.
The invention provides the advantages of securely retaining markers
within a marker delivery device, improving accuracy and avoiding
errors in placement of markers at desired locations within a
patient's body, preventing ingress of tissue into the distal tip of
the device when it is advanced through tissue, and guiding the
device by use of an imaging device including ultrasound, X-ray and
magnetic resonance based devices.
These and other advantages of the invention will become more
apparent from the following description when taken in conjunction
with the accompanying drawings.
BRIEF DESCRIPTION OF THE DRAWINGS
FIG. 1A is a partly cut-away perspective view of a marker delivery
assembly embodying features of the invention.
FIG. 1B is a transverse cross-sectional view of the marker delivery
assembly of FIG. 1A taken at line 1B-1B.
FIG. 1C is a transverse cross-sectional view of the marker delivery
assembly of FIG. 1A taken at line 1C-1C.
FIG. 2 is an end perspective view of a fibrous marker with a core
member suitable for use with a marker delivery system embodying
features of the invention.
FIG. 3 is an end perspective view of an alternative fibrous marker
without a core member suitable for use with a marker delivery
system embodying features of the invention.
FIG. 4A-4F illustrates forming a fibrous marker with a core member
as depicted in FIG. 4.
FIG. 5 is a partially cut away, perspective view of a human breast
from which a biopsy specimen has been removed, showing a markers
being delivered to the biopsy site with the marker delivery
assembly shown in FIG. 1A.
FIG. 6 is a partial cut-away view of a human breast shown in FIG. 2
with the markers delivered into the biopsy site and the delivery
device removed.
FIG. 7 is a longitudinal cross-sectional view of the distal portion
of an alternative marker delivery device embodying features of the
invention with a sharp, tissue penetrating distal tip.
FIG. 8 is a longitudinal cross-sectional view of the distal portion
of a marker delivery device embodying features of the invention
having particulate marker mass proximal to the releasable plug.
DETAILED DESCRIPTION OF EMBODIMENTS OF THE INVENTION
FIGS. 1A-1C illustrate a marker delivery device 10 embodying
features of the invention which includes a delivery tube or cannula
11 with a bore 12, a distal portion 13, and a proximal portion 14
with a handle 15. A releasable distal plug 16, several (five) short
term markers 17, a pair of fibrous markers 18 and 19 and a proximal
plug 20 are shown disposed within the bore 12. A plunger 21 is
slidably disposed within the tube bore 12, and is provided with a
proximal end 22 configured to allow an operator to press the
plunger further into the bore 12 and push the releasable plug 16
and one or more of the other markers out of the discharge port or
opening 23 in the distal end 24 of delivery tube 11. Cannula handle
15 allows an operator to hold the cannula steady while pressing
plunger 21 to discharge the releasable plug 16 and markers 17 and
18.
Releasable plug 16 may substantially fill the discharge opening 23,
as shown in FIG. 1, or may occupy or block only a portion of the
discharge opening 23. The exposed face of plug 16 is preferably
provided with an inclined configuration to conform with the
inclination of the discharge opening 23.
Markers 17, 18 and 19 and proximal plug 20 are preferably
configured to slide readily within tube bore 12. Releasable plug 16
is configured to be tight enough, e.g. press fit, in the bore 12 to
prevent its inadvertent release which would allow premature
discharge of markers 17, 18 and 19 from delivery tube 11 and
undesirable contact with body fluid. But the plug 16 must be easily
released when the plunger 21 is pressed deeper into the bore 12 of
the delivery tube 11. An adhesive or mechanical element(s) may be
used to hold the releasable plug 16 in a position within the bore
12 to occlude the discharge opening 23. Suitable adhesives include
polyurethane or polyacrylic based adhesives,
polyhydroxymethacrylate base adhesives, fibrin glue (e.g.,
Tisseal.TM.), collagen adhesive, or mixtures thereof. Suitable
mechanical means for securing the releasable plug 16 are described
in application Ser. No. 10/174,401, now U.S. Pat. No. 7,651,505,
which has been incorporated herein. The distal end 24 of the
delivery cannula 11 is provided with a ramp 25 which guides the
discharged plug 16 and markers 17, 18 and 19 out of the side port
26 into the target site. The distal tip 27 may be tapered for
delivery through a guide tube as shown.
The delivery tube 11 may be provided with markings 28 which serve
as visual landmarks to aid an operator in accurately placing the
distal end 24 of the cannula 11 in a desired location within a
patient's body for discharging the markers. The markings 37 also be
radiopaque, ultrasound-reflective, or otherwise configured to be
detectable by remote imaging devices and imaging methods.
Short term markers 17 are made at least in part with detectable,
biocompatible materials. Suitable marker materials include
bioresorbable polymeric materials such as poly(esters),
poly(hydroxy acids), poly(lactones), poly(amides),
poly(ester-amides), poly(amino acids), poly(anhydrides),
poly(ortho-esters), poly(carbonates), poly(phosphazines),
poly(thioesters), poly(urethanes), poly(ester urethanes),
polysaccharides, polylactic acid, polyglycolic acid, polycaproic
acid, polybutyric acid, polyvaleric acid, and copolymers, polymer
alloys, polymer blends, and combinations thereof. Preferable
polymeric materials are polymers of lactic acid, glycolic acid and
caprolactones. The short term markers 17 may also be formed at
least in part of gelatin. One or more of the short term markers 17
may include a remotely detectable preferably radiopaque element
28.
Releasable plug 16 is preferably formed at least in part of
oxidized regenerated cellulose or polyethylene glycol, but may be
made from the same or similar bioabsorbable materials as marker 17.
The polyethylene glycol quickly expands when contacting a water
based fluid such as blood, which ensures that the releasable plug
seals off the discharge opening to prevent premature contact
between body fluid (or other water based fluid) and the markers 17,
18 and 19 within the bore 12. The polyethylene glycol should have a
molecular weight of about 5000 to about 20000 Daltons, preferably
about 8000 to about 10000 Daltons in the final plug form. The
releasable plug 16 preferably has a non-magnetic element 29
incorporated within the body of the releasable plug that is
remotely detectable by magnetic resonance imaging (MRI). It may be
formed of titanium, platinum, gold, iridium, tantalum, tungsten,
silver, rhodium and the like. The MRI detectable element 29 should
have a maximum dimension of about 0.5 to about 5 mm, preferably
about 1 to about 3 mm to be MRI detectable. Elements with
dimensions greater than about 5 mm tend to interfere with the
imaging of adjacent tissue.
Releasable plug 16, markers 17, 18 and 19, and plug 20 are
configured for a slidable fit within the bore 12 of the delivery
tube 11. The exterior of the delivery tube 11 is preferably
configured to fit within a guide cannula sized to accept a
Mammotome.RTM., Tru-Cut.RTM., or SenoCor.RTM. biopsy device.
Typically, plug 16 and markers 17 and 18 will have diameters
determined by the size of the bore 12 and typically will be about
0.02 inch (0.5 mm) to about 0.5 inch (12 mm), preferably about 0.04
inch (1 mm) to about 0.3 inch (8 mm). Plug 16 may have slightly
larger transverse dimensions to provide a tight fit. In addition,
plugs 16 and 20 and short term markers 17 will have a length of
about 0.04 inch (1 mm) to about 0.8 inch (20 mm), preferably about
0.1 inch (2.5 mm) to about 0.6 inch (15 mm).
The fibrous markers 18 and 19 are preferably rolled or folded
pieces of fibrous material such as oxidized cellulose or oxidized,
regenerated cellulose which has been compressed and impregnated
with a binding agent such as polyethylene glycol and freeze dried
in the compressed condition. The fibrous material may be rolled up
by itself, as shown in FIG. 3, or wrapped as an outer jacket about
a matt-like core 30 as shown in FIG. 2. The fibrous marker is
generally configured to be slidably disposed within the inner lumen
of the delivery cannula 11, and before delivery is about 0.5 mm to
about 12 mm, preferably about 1 to about 8 mm in diameter and about
5 to about 30 mm, preferably about 10 to about 25 mm in length.
Upon contact with a body fluid or other water based fluid, the
length of the fibrous marker remains about the same but the wrapped
structure unfolds upon swelling to a width of about 5 to about 25
mm, usually about 10 to about 20 mm. With a radiopaque marker
element clamped about a center portion of the wrapped fibrous
marker, the fibrous marker expands into a generally bow-tie shape
when exposed to body fluids. However, even though secured to the
fibrous marker, the radiopaque marker element need not restrict the
expansion of the fibrous marker.
The manufacture and use of an embodiment of a fibrous elongated
intracorporeal marker 18 with core 30 of bioabsorbable fibers is
schematically illustrated in FIGS. 4A-4F. In the embodiment, as
shown in FIGS. 4C-4E, core 30 has a longitudinal extent and a pair
of opposed ends. An outer jacket 33 of bioabsorbable fibers is
disposed around the elongated longitudinal extent of core 30, with
the pair of opposed ends being exposed.
A felt pad or mat 31 of oxidized, regenerated cellulose about 0.125
to about 0.375 inch (3.2-9.3 mm), preferably about 0.25 inch (6.4
mm) thick is impregnated with a 10% (Wt.) polyethylene glycol in a
70% isopropyl alcohol solution and then compressed to a mat about
0.03 to about 0.05 inch (0.76-1.3 mm) thick. A reduction in
thickness of 80% or more is suitable. The compressed mat 31 is cut
up into elongated strips 32 with square or near square transverse
cross-sectional shapes which form the core 30. The core 30 is
wrapped in a fabric 33 (i.e., the outer jacket) of oxidized
regenerated cellulose about 5 to about 10 mm in width and about 20
mm in length, compressed and impregnated with the 10% PEG
dispersion and then freeze dried to a diameter of about 0.065 inch
(1.65 mm). Elevated temperatures may be employed to dry the
material. The fabric 33 should make at least one, preferably two or
more complete wraps about the core 30. The wrapped and compressed
product may then be cut to a desired length to form the fibrous
marker 18. Alternatively, the uncompressed mat 31, the strip 32 and
fiber wrap 33 may be provided at the desired length for the fibrous
marker 18, wrapped and then compressed.
The fiber wrap (i.e., outer jacket) 33 may be formed, at least in
part, from a bioabsorbable material, such as for example, a
material comprised of at least one of oxidized cellulose, oxidized
regenerated cellulose, polylactic acid, a copolymer of polylactic
acid and glycolic acid, and polycaprolactone. Also, the fiber wrap
(i.e., outer jacket) 33 may be a woven fabric.
A radiographically detectable marker element 34 may be formed of a
radiopaque wire about 0.005 to about 0.01 inch (0.13-0.25 mm), and
may then be disposed around, e.g., crimped about, or embedded in, a
central portion (or other desired portion) of the marker 18. The
fibrous marker 18 is then ready for deployment. As shown in FIG.
1A, only fibrous marker 18 is provided with marker element 34.
Marker 19 may be formed in the same or similar manner but without
the radiopaque element 34.
Fibrous markers without the core member 30 may be formed by rolling
or folding into the desired configuration. The fibrous material,
oxidized rayon felt is first impregnated with a 10% PEG dispersion,
compressed and then freeze dried. The dried felt material is rolled
again compressed in the rolled state, impregnated with a 10-30% PEG
solution, and freeze dried in the rolled compressed condition. The
rayon felt material can be initially oxidized by treating in a
solution of 80% (by vol.) Nitric Acid, 20% (by vol.) Sulfuric Acid
and 1% (by weight) Sodium Nitrite. The felt is treated in the
oxidizing, acidic solution at room temperature for about 4.5 hours
and then rinsed with deionized water.
Radiopaque elements 28 and 34 may be made with suitable radiopaque
material, including stainless steel, platinum, gold, iridium,
titanium, tantalum, tungsten, silver, rhodium, nickel, bismuth,
other radiopaque metals, alloys and oxides of these metals, barium
salts, iodine salts, iodinated materials, and combinations of
these. The radiopaque elements 28 and 34 may also be configured for
detection by MRI. Radiopaque materials and markers may be
permanent, or may be temporary and not detectable after a period of
time subsequent to their placement within a patient. Colorants,
such as dyes (e.g., methylene blue and carbon black) and pigments
(e.g., barium sulfate), may also be included in markers 17 and 19
and plugs 16 and 20 embodying features of the invention.
FIG. 5 schematically illustrates the use of a marker delivery
system 10 to deliver markers to a desired location 35 within a
patient's body. The desired location 35 is typically a cavity from
which a biopsy sample has been, or is to be, taken, or a lesion
that has been or will be removed or otherwise treated. In FIG. 5,
the marker delivery system 10 is shown inserted into a breast 40
through a guide cannula 41 until the distal end 24 is disposed at
the delivery site, cavity 35 where a tissue specimen has been
removed. While an operator holds the system 10 by the handle 15 of
the delivery tube 11, the plunger 21 is pressed further into the
bore 12 of delivery cannula 11 to discharge the releasable plug 16
and markers 17, 18 and 19 into the cavity 35. FIG. 6 schematically
illustrates the plug 16 and markers 17, 18 and 19 within the cavity
35 after deployment. When the markers contact body fluid within the
cavity 35, they tend to swell and thereby further fill the cavity.
The fibrous markers 18 and 19 generally block the accessing track
36 to the cavity 35 so that none of the smaller markers 17 will be
lost through the track 36. Marks 37 are provided on the proximal
end of cannula 11 to provide end location information to the
operator.
FIG. 7 illustrates the distal portion 50 of cannula 51 of an
alternative delivery system that is essentially the same as that
shown in FIGS. 1A-1C except that the distal tip 52 of cannula 51 is
configured in a needle-like shape. The delivery system cannula 51
may be used in conjunction with a guide cannula (not shown) or the
cannula 51 can be inserted directly through tissue to reach the
target site without the need for a guide cannula. The releasable
plug 53 is secured in the discharge opening 54 as in the previously
discussed embodiment. The exposed face 55 of the plug 53 is
preferably flush with the discharge opening 54 of the distal tip
52.
Insertion of marker delivery devices embodying features of the
invention may be performed with or without the aid of an imaging
device, such as an ultrasound imaging device, an X-ray imaging
device, a MRI device, or other imaging device. Alternatively, or
additionally, insertion may be visually guided, or may be guided by
palpation or by other means.
The size and composition of the short term markers 17 are selected
so as to remain in place within the patient and be detectable by
ultrasound for at least 2 weeks, preferably at least 6 weeks to
have practical clinical value. However, the short term markers
should not be detectable by ultrasound after about one year,
preferably not after about six months, so as to avoid interfering
with subsequent site examination. For most clinical purposes, a
suitable in-situ lifespan when the short term marker is
ultrasonically detectable is about six to about twenty weeks. The
radiopaque and MRI detectable marker elements generally will have
much longer lifespans.
FIG. 8 illustrates the distal shaft section 60 of an alternative
delivery cannula 61 which has a fibrous releasable plug 62 in the
inner lumen 63 of the distal shaft section which at least partially
occludes the discharge opening 64 in the distal end of the shaft.
The fibrous releasable plug 62 may be formed as shown in FIGS. 2, 3
and 4A-F.
The inner lumen proximal to the fibrous releasable plug 62 is
filled with a particulate marker material 65. The corresponding
parts of the system are the same as that shown in FIGS. 1A-1C.
Plunger 66 is slidably disposed within the inner lumen 63 to eject
the powdered mass 65. The particulate marker material 65 may be
discharged dry or mixed with a suitable fluid and discharged as a
slurry.
The particulate may be formed of a biocompatible and bio-resorbable
polymeric material such as polylactic acid, polyglycolic acid,
polycaprolactones, poly(esters), poly(hydroxy acids),
poly(lactones), poly(amides), poly(ester-amides), poly(amino
acids), poly(anhydrides), poly(ortho-esters), poly(carbonates),
poly(phosphazines), poly(thioesters), poly(urethanes), poly(ester
urethanes), polysaccharides, polybutyric acid, polyvaleric acid,
and copolymers, polymer alloys, polymer mixtures, and combinations
thereof. Of those, polylactic acid, polyglycolic acid, and
polycaproic acid are preferred. The polymeric material in
particulate form should have cavities or entrap bubbles which
facilitate remote detection.
Suitable particulate materials have particle sizes typically about
20 microns to about 2000 microns, preferably about 20 microns to
about 800 microns and more preferably about 300 microns to about
500 microns. The particulate should have cavities for USI with
maximum dimensions of about 10 microns to about 500 microns,
preferably about 20 microns to about 200 microns. The polymeric
particulate materials suitable for use in making
ultrasound-detectable biopsy marker materials typically have a bulk
density of about 0.8 g/ml to about 1.5 g/ml, preferably about 0.8
g/ml to about 1 g/ml. The particulate may also contain or be mixed
with binding agents such as polyethylene glycol, polyvinyl alcohol
and the like. Polysaccharide particulate or powder may be
incorporated into the particulate mass in amounts up to about 50%
(by weight) of the total particulate mass for purposes of
hemostasis.
While particular forms of the invention have been illustrated and
described herein in the context of a breast biopsy site, it will be
apparent that the device and methods having features of the
invention may find use in a variety of locations and in a variety
of applications, in addition to the human breast. Moreover, various
modifications can be made without departing from the spirit and
scope of the invention. Accordingly, it is not intended that the
invention be limited to the specific embodiments illustrated. It is
therefore intended that this invention to be defined by the scope
of the appended claims as broadly as the prior art will permit, and
in view of the specification if need be. Moreover, those skilled in
the art will recognize that features shown in one embodiment may be
utilized in other embodiments. Terms such as "element", "member",
"device", "section", "portion", "step", "means" and words of
similar import when used in the following claims shall not be
construed as invoking the provisions of 35 U.S.C. .sctn.112(6)
unless the following claims expressly use the terms "means"
followed by a particular function without specific structure or
"step" followed by a particular function without specific action.
All patents and patent applications referred to above are hereby
incorporated by reference in their entirety.
* * * * *
References